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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Arthrex® - 00888867295667

36/24 Glenosphere
ARTHREX, INC.
AR-9564-2436
In Commercial Distribution

  • 00888867295667 ()
AR-9564-2436

  • Total reverse shoulder prosthesis

Arthrex® - 00888867295643

33/24 Glenosphere
ARTHREX, INC.
AR-9564-2433
In Commercial Distribution

  • 00888867295643 ()
AR-9564-2433

  • Total reverse shoulder prosthesis

CoolCard - 00816417020407

CoolCard - 24 Cycle
Zeltiq Aesthetics, Inc.
BRZ-CD4-06X-024
In Commercial Distribution

  • 00816417020407 ()
BRZ-CD4-06X-024

  • Cryolipolysis body contouring system program card

Sklar® - 10649111307768

EXTRACTING FORCEP #24
SKLAR CORPORATION
49-4100
In Commercial Distribution

  • 10649111307768 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Sklar® - 10649111290787

EXTRACTING FCPS #24
SKLAR CORPORATION
48-226
In Commercial Distribution

  • 10649111290787 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Marketlab - 00817517026573

Horizon 24 Centrifuge
MARKETLAB INC.
108142
In Commercial Distribution

  • 00817517026573 ()


  • General-purpose centrifuge IVD

Biomet EBI Bone Healing System - 00812301020539

SFLX 2-4 COIL
EBI, LLC
1068228
In Commercial Distribution

  • 00812301020539 ()
1068228

  • Patient-worn bone growth electromagnetic stimulator

KENTEX - 00810003753571

CARDBOARD SPLINT 24"
KENTRON HEALTHCARE, INC.
826018
In Commercial Distribution

  • 00810003753588 ()
  • 00810003753571 ()


  • General-purpose medical foam padding, single-use

SchureMed - 00810014601854

TKR Positioner, 24"
SCHUERCH CORPORATION
800-0141
In Commercial Distribution

  • 00810014601854 ()


  • Leg procedure positioner

Fresh Cells - 30014613334446

LLC-MK2 W48/24
DIAGNOSTIC HYBRIDS, INC.
86-4824
In Commercial Distribution

  • 30014613334446 ()
86-4824

  • Cell culture line IVD
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